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CompletedNCT06147115Updated Nov 27, 2023

The Validation of Rockall Scoring System in Predicting Outcomes From Variceal Bleeding

An observational study in Bleeding Esophageal, sponsored by National Center for Gastroentestinal and Liver Disease. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by National Center for Gastroentestinal and Liver Disease · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

Objective This study aims to evaluate the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients.

Design/Method A cross-sectional hospital-based study involved 150 adult Sudanese patients presenting with upper gastrointestinal bleeding (UGIB) of variceal origin. Patients with UGIB resulting from causes other than varices and those who declined participation were excluded. Data were collected through a structured questionnaire complemented by upper gastrointestinal tract endoscopy findings, and patients were followed up until discharge.

Results The study encompassed 150 patients, predominantly male (117, 78%), aged between 18 and 60 years (n=119, 79%), residing mainly in central regions (134, 89%). The leading presenting complaints included hematemesis (70, 46.7%) and melena (22, 14.6%). Notably, peri-portal fibrosis (101, 67.3%) and cirrhosis (24, 16%) were the primary etiological factors, with a significant prevalence of alcohol consumption (87, 58%). Concerning the grade of esophageal varices, grades III and IV were most prevalent (67, 44.7% and 47, 31.3%, respectively), and fundal varices were identified in 13 patients (8.7%). The mean Rockall score was 3.83 ± 1.99, indicating moderate severity. Additionally, the Rockall score showed significant associations with the number of sessions, complications, bleeding recurrence, duration of hospital stay, and mortality (p \< 0.05).

Conclusion Understanding the significance of the Rockall scoring system and its applicability to Sudanese patients with variceal bleeding has the potential to guide more effective strategies in the management of upper gastrointestinal tract bleeding, ultimately improving patient outcomes and reducing morbidity and mortality.

02

Conditions studied

  • Bleeding Esophageal
03

In context

Lead sponsor

National Center for Gastroentestinal and Liver Disease is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

A total of 150 patients were enrolled in the study between June and September 2012. The study comprised patients aged 18 years and older, presenting with upper gastrointestinal (GI) bleeding of variceal origin, who visited the outpatient and referral clinic at the center and reported primary complaints of upper GI bleeding (UGIB), including hematemesis and/or melena. Patients with upper GI bleeding resulting from causes other than varices, as well as those who declined to participate in the study, were excluded

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • aged 18 years and older
  • primary complaints of upper GI bleeding

Exclusion criteria

Exclusion Criteria:

  • Patients with upper GI bleeding resulting from causes other than varices
  • who declined to participate in the study
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No

Interventions

  • OtherAssessment tool to determine severity of GI bleeding

    The Rockall score is a validated mortality risk assessment for patients admitted with upper GI bleeding.

06

What researchers measure

Primary outcomes

  1. the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients

    The primary outcome measure in this study appears to be the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients presenting to the Mohammed Salih Idris Bleeding Center (MSIBC). The study aims to assess the effectiveness of the Rockall scoring system in predicting mortality, bleeding recurrence, and other clinical outcomes in Sudanese patients with variceal bleeding. The Rockall scoring system incorporates various factors, including age, evidence of shock, coexisting medical conditions, and the presence of visible signs of hemorrhage. The study investigates the association between Rockall scores and clinical outcomes such as mortality, bleeding recurrence, complications, duration of hospital stay, and interventions conducted. The validation of the Rockall scoring system in the context of variceal bleeding in Sudan is crucial for risk stratification and guiding the management of patients with variceal bleeding.

    Time frame: June 2012 - Sep 2012

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06147115
Lead sponsor
National Center for Gastroentestinal and Liver Disease
Responsible party
Sponsor
First posted
Nov 27, 2023
Start date
Jun 1, 2012
Primary completion
Sep 1, 2012
Completion
Sep 10, 2012
Last update
Nov 27, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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